N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC— 510(k) K083445
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K083445 for N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC, Substantially Equivalent on 2009-03-24. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code CFN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code CFN
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Recalls naming K083445
K-number listed on FDA's recall record- Z-0093-2023 — N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
- Z-0094-2023 — N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083445.
Data sourced from openFDA. This site is unofficial and independent of the FDA.